Panacea Biotec Pharma Limited — EU GMP NCR (EudraGMDP) Findings

Critical observations: 1. The Site Master File did not indicate the outcome of the listed inspections and audits. The failed inspection, leading to OAI status, conducted by the US FDA in 2023 was not reported. 2. Deficiencies of IT systems and CSs management were identified as: - the ERP system was not indicated on the lists of computerized systems, and it was not validated, the validation had not yet started at the time of the inspection. The system was commissioned on 05.04.2025. - backup restoration check was not performed in 2025, although it was SOP requirement. Planner and performed restoration checks in 2026 were presented. - there was no clear requirement to verify the validity of data stored in a system before its decommissioning. 3. The gowning qualification monitoring points did not include the backplane of the body and the lower legs for operators who entered the Grade A with their whole body (back of the head, back, bottom). For operators in Grade A and B, only the five finger dabs were monitored, not the whole fingers. The personal monitoring did not take into consideration the non-routine interventions where – occasionally – an operator or engineer had to enter into Grade A with body parts which were not part of the routine monitoring plan. This is a recurring observation from the US FDA report from 2023. Major observations: 1. The dryer used for the drying of pre/fine filters of AHUs in OSD, was dirty. Recurring observation. 2. • Weaknesses identified in the CCS were the followings: - The opening/closing mechanism of the automatic door leading to the Grade B filling room (type DORMA ED 100/ED 250 and the risks and necessary controls related to its mechanism were not captured. - No Contamination Control Strategy (microbial) was developed for the OSD block (especially for oral liquids and ointments/cremes). - The CCS failed to capture risks specific to certain materials and items, transferred through DPBs with wet mopping and with or without removal of wrapping. As a consequence, CAPA and monitoring programme were not established for those items. - Joints of the robotic arm used in C-RABS were not identified as hard to disinfect locations, the VHP cycle validation therefore did not address these joints. 3. The conditions triggering anaerobic aseptic process simulation and the pre-requisites necessary to perform such a simulation were not defined in the APS procedure. Non-inherent (corrective) interventions were required to be performed only annually. Durations and number (count) of corrective interventions were not defined in the APS protocol. Corrective interventions performed with open C-RABS door were defined, however only one of the six types was required to be performed per APS and the duration and count of these interventions was not defined. Visual inspection findings (other than intactness issues) were not reported for the APS batches (e.g. particles, fibers and other contaminations). Action taken/proposed by the NCA: Withdrawal, of current valid GMP certificate No. OGYÉI/496-7/2022, NNGYK/07707-2/2026 All certificates revoked. Recall of batches already released The inspectors did not observe any behaviour or manufacturing process that would pose risk to the quality of products already released. Prohibition of supply The NCPHP proposes halting of supplies, except those supplying patients being on treatment with the oncology products. Non-vital supplies are proposed to be halted. Suspension of clinical trials The NCPHP has no information about clinical trials with IMPs from the site